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CoronaVac vaccination schedules in adults
NCT04651790Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2020
- Primary completion
- Aug 2022
- Countries
- 1
- Sponsor
- Pontificia Universidad Católica de Chile
- Modality
- Whole Inactivated Vaccines
- Drugs
- coronavac
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, open-label trial of coronavac in coronavirus disease 2019 (COVID-19) (2 arms), sponsored by Pontificia Universidad Católica de Chile. Primary endpoints: Frequency of solicited and unsolicited adverse events and Incidence of symptomatic cases of virologically confirmed COVID-19 up to 1 year. Started Nov 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Vaccine 0-14
CoronaVac administered at Day 0 and Day 14
Vaccine 0-28
CoronaVac administered at Day 0 and Day 28
03
Who it enrols
Adults over 18 years without prior COVID-19, uncontrolled chronic diseases, or immunosuppression.
04
Endpoints
Primary
Frequency of solicited and unsolicited adverse events
Incidence of symptomatic cases of virologically confirmed COVID-19
Secondary
Incidence of hospitalized cases of COVID-19
Incidence of severe cases or deaths of COVID-19
Incidence of adverse reactions to the vaccine
Incidence of serious adverse events (SAE)
Percentage of participants with significant increase in SARS-CoV-2 specific T cells
Percentage of participants with significant increase of anti-SARS-CoV-2 antibodies
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